CMC, GMP & Quality Assurances Consultant
Posted 30 days ago · 0 applicants
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The role in plain words
- Degree in a scientific discipline
- 5-8 years of pharmaceutical QA experience with CMC
- Strong knowledge of GMP, ICH guidelines, and outsourced quality oversight
- Excellent technical review, communication, and organizational skills
Extracted from the job description · kept up to date automatically
Who this suits
Full job description
Original listing · kept for referencePosition Summary
The QA Contractor will provide Quality Assurance oversight of outsourced CMC activities performed by CROs, and analytical laboratories. The role is responsible for ensuring that all CMC activities and deliverables comply with applicable GMP, ICH, FDA/EMA, and company quality requirements.
Key Responsibilities
• Provide QA oversight of outsourced CMC activities and external service providers.
• Review and approve CMC-related documents, including protocols, reports, batch records, specifications, deviations, CAPAs, change controls, and validation documentation.
• Review quality events, investigations, and risk assessments, ensuring timely resolution.
• Support vendor qualification, audits, and ongoing quality performance.
• Support CMC regulatory submissions and inspection readiness.
• Identify quality risks and provide QA guidance to cross-functional teams.
Qualifications
• Degree in a scientific discipline.
• 5–8 years of pharmaceutical QA experience with CMC.
• Strong knowledge of GMP, ICH guidelines, and outsourced quality oversight.
• Excellent technical review, communication, and organizational skills.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- Degree in a scientific discipline, 5-8 years of pharmaceutical QA experience with CMC, Strong knowledge of GMP, ICH guidelines, and outsourced quality oversight, Excellent technical review, communication, and organizational skills